Expanded Access For Lorlatinib For Patients With Non Small Cell Lung Cancer ALK Positive or ROS1 Positive

NCT03178071

Last updated date
Study Location
Arizona Oncology Associates, PC - NAHOA
Sedona, Arizona, 86336, United States
Contact
1-800-718-1021

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non Small Cell Lung Cancer ALK Positive or ROS1 Positive
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Ineligibility for participation in any ongoing clinical study of the investigational product

- Age ≥18 years

- Histologically or cytologically diagnosis of metastatic NSCLC that carries an ALK rearrangement or a ROS1 rearrangement

- For ALK positive patients: failure to prior treatment with at least one ALK-TKI. If prior ALK-TKI was crizotinib, additional prior treatment required with at least one second generation ALK-TKI registered and commercially available. For patients with resistance mutations not covered by other inhibitors (eg, ALK G1202R resistance mutation), prior treatment with an ALK/ROS1 inhibitor is not required.

- For ROS1 positive patients: failure to prior treatment with at least crizotinib

- Adequate bone marrow, liver, renal, pancreatic functions

- Negative pregnancy test at screening

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Previous surgery, chemotherapy, radiotherapy or other anti cancer therapy or
participation in other studies with investigational drugs within the timeframe
indicated in the protocol


- History of interstitial fibrosis or interstitial lung disease


- Concomitant use of prohibited medication


- Clinically significant cardiovascular disease: cerebral vascular accident/stroke,
myocardial infarction, unstable angina, congestive heart failure, second degree or
third degree atrioventricular block (unless paced) or any AV block with PR >220 msec


- Ongoing cardiac dysrhythmias, uncontrolled atrial fibrillation,bradycardia, ECG with
QTc >470 msec, or congenital long QT syndrome


- History of or predisposing characteristics for acute pancreatitis

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Non Small Cell Lung Cancer ALK Positive or ROS1 PositiveExpanded Access For Lorlatinib For Patients With Non Small Cell Lung Cancer ALK Positive or ROS1 Positive
NCT03178071
  1. Sedona, Arizona
  2. Huntington Beach, California
  3. Irvine, California
  4. Long Beach, California
  5. Long Beach, California
  6. Oakland, California
  7. Orange, California
  8. Orange, California
  9. Sacramento, California
  10. San Francisco, California
  11. Vallejo, California
  12. Pembroke Pines, Florida
  13. Athens, Georgia
  14. Chicago, Illinois
  15. Chicago, Illinois
  16. Elmhurst, Illinois
  17. Naperville, Illinois
  18. Boston, Massachusetts
  19. Boston, Massachusetts
  20. Boston, Massachusetts
  21. Boston, Massachusetts
  22. Ann Arbor, Michigan
  23. Detroit, Michigan
  24. Detroit, Michigan
  25. Detroit, Michigan
  26. Farmington Hills, Michigan
  27. Creve Coeur, Missouri
  28. Saint Louis, Missouri
  29. Saint Louis, Missouri
  30. Saint Peters, Missouri
  31. New Brunswick, New Jersey
  32. East Setauket, New York
  33. New York, New York
  34. New York, New York
  35. New York, New York
  36. Patchogue, New York
  37. Port Jefferson Station, New York
  38. Cincinnati, Ohio
  39. Columbus, Ohio
  40. Columbus, Ohio
  41. Columbus, Ohio
  42. Columbus, Ohio
  43. Columbus, Ohio
  44. Columbus, Ohio
  45. Gahanna, Ohio
  46. Pittsburgh, Pennsylvania
  47. Charleston, South Carolina
  48. Dallas, Texas
  49. Seattle, Washington
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Expanded Access For Lorlatinib For Patients With Non Small Cell Lung Cancer ALK Positive or ROS1 Positive
Official Title AN EXPANDED ACCESS PROTOCOL FOR LORLATINIB FOR TREATMENT OF PATIENTS WITH ADVANCED NON-SMALL CELL LUNG CANCER HARBORING SPECIFIC MOLECULAR ALTERATIONS
Brief Summary This expanded access study has being designed following a demand from the FDA, given the increase in the number of request for single patient INDs for lorlatinib
Detailed Description Given that an Expanded Access study does not meet the definition of a controlled clinical investigation, and as such, is not considered an applicable drug clinical trial per NIH, Basic Results for such studies are not required to be reported. Protocol B7461020 has been identified as an Expanded Access trial, and has been registered to ClinicalTrials.gov, however Basic Results will not be posted. This statement has been placed in the Detailed Description section of the protocol registration on ClinicalTrials.gov.
Study Type Expanded Access
Expanded Access Type Individual Patients
Condition Non Small Cell Lung Cancer ALK Positive or ROS1 Positive
Intervention Drug: Lorlatinib
oral tablets, administered daily, continuously
Other Name: PF-06463922
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status No longer available
Eligibility Criteria

Inclusion Criteria:

  • Ineligibility for participation in any ongoing clinical study of the investigational product
  • Age ?18 years
  • Histologically or cytologically diagnosis of metastatic NSCLC that carries an ALK rearrangement or a ROS1 rearrangement
  • For ALK positive patients: failure to prior treatment with at least one ALK-TKI. If prior ALK-TKI was crizotinib, additional prior treatment required with at least one second generation ALK-TKI registered and commercially available. For patients with resistance mutations not covered by other inhibitors (eg, ALK G1202R resistance mutation), prior treatment with an ALK/ROS1 inhibitor is not required.
  • For ROS1 positive patients: failure to prior treatment with at least crizotinib
  • Adequate bone marrow, liver, renal, pancreatic functions
  • Negative pregnancy test at screening

Exclusion Criteria:

  • Previous surgery, chemotherapy, radiotherapy or other anti cancer therapy or participation in other studies with investigational drugs within the timeframe indicated in the protocol
  • History of interstitial fibrosis or interstitial lung disease
  • Concomitant use of prohibited medication
  • Clinically significant cardiovascular disease: cerebral vascular accident/stroke, myocardial infarction, unstable angina, congestive heart failure, second degree or third degree atrioventricular block (unless paced) or any AV block with PR >220 msec
  • Ongoing cardiac dysrhythmias, uncontrolled atrial fibrillation,bradycardia, ECG with QTc >470 msec, or congenital long QT syndrome
  • History of or predisposing characteristics for acute pancreatitis
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03178071
Other Study ID Numbers B7461020
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2019